MAUDE Adverse Event Report: VERYAN MEDICAL LTD BIOMIMICS 3D VASCULAR STENT SYSTEM

Catalog Number 131816-10

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577); Insufficient Information (3190); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2022

Event Type  Injury  

Manufacturer Narrative

The complaint investigation is in progress.Any additional information received will be provided in a supplemental follow-up report.

Event Description

On (b)(6) 2022 during a procedure to treat a lesion of the superficial femoral artery (sfa) , a 6 x 100mm biomimics 3d stent was advanced using an ipsilateral approach.The lesion had been prepared using plain old balloon angioplasty (poba).A 6 fr sheath and 0.035" guidewire were used.There was no vessel occlusion reported.The iliac vessels were normal and not considered tortuous.The physician reported resistance at initiation of deployment and retraction of the bifurcation hub was difficult.However, the delivery system was not flushed in accordance with the ifu.As a result the stent was difficult to release which culminated in the proximal edge of the stent not opening fully.The target site was ballooned again and a competitor stent was used to resolve the partially open proximal end of bm3d stent.There is no reported impact to the patient and the physician is uncertain if the device was related to the event.

Manufacturer Narrative

The device was not returned for evaluation as the stent remains implanted and the original angiographic images were not provided.The complaint investigation included the following: 1) communication/interviews: a list of questions were sent to the complaint site to gather more information on the procedural details.The site provided the following information: the target site was the superficial femoral artery (sfa).An ipsilateral approach was used.The target site was prepared using plain old balloon angioplasty (poba).A 6fr access sheath was used and a 0.035" guidewire.The iliac arteries were described as being normal tortuosity.There was no vessel occlusion reported.The device was not flushed in accordance with the ifu.There was resistance felt at the initiation of deployment.The retraction of the bifurcation hub was described as difficult.The pin luer was held in a fixed position as per the ifu.The bm3d stent deployed however the proximal end of the stent did not open fully.The vessel was ballooned again after removal of the bm3d delivery system and a competitor stent was used to open the proximal end of the stent.The outcome of the patient was reported as good.A request was made by veryan's clinical sales specialist at a meeting with the physician for the angiography images but it was affirmed that the angiographic images would not be made available.2) investigative determination: the investigation identified that the device was not flushed as per the ifu.Flushing the delivery system is a required step in device preparation prior to insertion of the delivery system into the patient.The primary purpose of flushing the device is to lubricate the delivery system.There are three flushes that need to be performed according to ifu.It is known by veryan that deployment of a biomimics 3d device without performing the required device flushes can possibly lead to deployment forces being higher than expected and this iwas reported from the complaint site as resistance during initiation of deployment and the difficult retraction of the bifurcation hub.On releasing the bm3d stent from the delivery system, the proximal end had not fully expanded.As there were no angiographic images provided from the site, it was not possible for the investigation team to determine the level of incomplete expansion reported.It is also not possible to determine the degree of vessel calcification in the target vessel.Calcification of the vessel may prevent the stent from fully expanding depending on the extensiveness, although this cannot be confirmed without imaging.Balloon angioplasty performed post stent deployment can be necessary to complete expansion of the bm3d although this is at the discretion of the physician.The ifu states that "if post-deployment dilation is required, dilate with an appropriately sizes pta balloon".Post dilation of the bm3d stent was performed in this case however the effects of this on the proximal end of the stent which is reported as not expanding fully cannot be confirmed.3) summary: the complaint was categorized as "stent did not fully open" and the root cause attributed to the resistance/difficult deployment was determined to be "user" as the flushing steps were not conducted as per the ifu.A root cause of the incomplete expansion of the proximal end of the stent could not be determined as was assigned "unknown".Section h.6.Has been updated to align with the conclusion of the investigation.If any additional information is made available a follow-up report will be submitted.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Type of Device: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL LTD; unit 11 galway technology park; parkmore road; galway city, H91 V E0H; EI H91 VE0H
• Manufacturer Contact: alan mcdonagh ; unit 11 galway technology park; parkmore road; galway city, H91 V-E0H ; EI H91 VE0H
• MDR Report Key: 15173447
• MDR Text Key: 297314059
• Report Number: 3011632150-2022-00067
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P180003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 131816-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other